Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
An Extension to Study Protocol CVAL489K2302 to Evaluate the Long Term Safety, Tolerability and Efficacy of Valsartan in Children 6 to 17 Years of Age With Hypertension, Versus Enalapril Treatment for 14 Weeks, or Combined With Enalapril Versus Enalapril for 66 Weeks in Chronic Kidney Disease Patients.
1 other identifier
interventional
250
9 countries
9
Brief Summary
The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hypertension
Started Jun 2007
Typical duration for phase_3 hypertension
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2007
CompletedFirst Posted
Study publicly available on registry
March 13, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
June 6, 2011
CompletedJuly 12, 2011
June 1, 2011
2 years
March 9, 2007
January 11, 2011
June 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients With Adverse Events
Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)
Secondary Outcomes (4)
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26
Core Baseline (Week 0) to Week 26
Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26
Week 26
Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20
Core Baseline (Week 0) to Week 20
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26
Core Baseline (Week 0) to Week 26
Study Arms (4)
CKD patients: Valsartan+enalapril
EXPERIMENTALCKD patients: Enalapril
ACTIVE COMPARATORNon-CKD patients: Valsartan
EXPERIMENTALNon-CKD patients: Enalapril
ACTIVE COMPARATORInterventions
Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
Eligibility Criteria
You may qualify if:
- Successful completion of 12 weeks of double-blind treatment in core protocol CVAL489K2302.
- Patients participating in study CVAL489K2302 who may have discontinued prematurely due to uncontrolled hypertension defined as MSSBP \> 20%, but \< 25% above the 95th percentile for age, gender, and height after visit 5, qualifies a patient for entry into this extension study.
You may not qualify if:
- Renal artery stenosis.
- Current diagnosis of heart failure (NYHA Class II-IV).
- Second or third degree heart block without a pacemaker.
- Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
- Clinically significant valvular heart disease.
- Patient that demonstrates clinically significant ECG abnormalities other than those associated with left ventricular hypertrophy and AV block controlled with a pacemaker.
- Previous solid organ transplantation except renal, liver or heart transplantation. Renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. Patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator.
- Patients who experienced any adverse events considered serious and drug related in protocol CVAL489K2302.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Sites in USA
East Hanover, New Jersey, 07936, United States
Sites in Belgium
Belgium, Belgium
Sites in France
France, France
Sites in Germany
Germany, Germany
Sites in Hungary
Hungary, Hungary
Sites in India
India, India
Sites in Italy
Italy, Italy
Sites in Poland
Poland, Poland
Sites in Turkey
Turkey, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study was prolonged from 14 to 66 wks for CKD patients only. Most CKD patients completed the initial 14 wk extension period prior to amendment approval and the study was terminated prematurely with 3 CKD patients progressing to a maximum of Visit 13.
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 9, 2007
First Posted
March 13, 2007
Study Start
June 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
July 12, 2011
Results First Posted
June 6, 2011
Record last verified: 2011-06